Clinical and Laboratory Standards Institute document EP18-A2—Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition recommends a quality management system for in vitro diagnostic test systems that is based on expert opinion, is practical to implement, and is applicable to various devices and settings, so sources of failure (potential failure modes) are identified, understood, and managed. This system will assist device manufacturers, regulators, accrediting agencies, and laboratory directors in ensuring correct results. It addresses regulatory considerations (eg, principles and accountability), recommends the development of a partnership between users and manufacturers, provides a source-of-failures matrix, and suggests approaches to quality monitoring/identification of the problems.

This document provides guidance for risk management activities that include risk analysis (Failure Modes and Effects Analysis [FMEA]), fault trees, and risk monitoring (Failure Reporting, Analysis, and Corrective Action Systems [FRACAS]). These approaches are based on best practices; practical to implement; applicable to all diagnostics assays; and scientifically based, so sources of failure are identified, understood, and managed. 

This guideline applies to in vitro diagnostic device (IVD) test systems used by providers of health care services in any setting. The scope of this guideline comprises testing components, locations, and users. Specifically, the testing components include preanalytical, analytical, and postanalytical (preexamination, examination, and postexamination) processes. 

This document is intended primarily for IVD manufacturers. However, it is also intended as an important reference for clinical laboratory directors and supervisors who wish to learn about risk management techniques and processes. Although the concept of risk reduction is not new in the laboratory, the risk management tools in this guideline may be new to laboratorians, and will create a need for laboratory directors and supervisors to gain an understanding of these techniques so they can apply these principles and processes in development of their customized quality plan. EP18 is intended to help in that effort.